Dyclonine hydrochloride - Generic Drug Details
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What are the generic drug sources for dyclonine hydrochloride and what is the scope of freedom to operate?
Dyclonine hydrochloride
is the generic ingredient in two branded drugs marketed by Astrazeneca and Septodont, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for dyclonine hydrochloride. One supplier is listed for this compound.
Summary for dyclonine hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 88 |
| Clinical Trials: | 2 |
| Patent Applications: | 956 |
| What excipients (inactive ingredients) are in dyclonine hydrochloride? | dyclonine hydrochloride excipients list |
| DailyMed Link: | dyclonine hydrochloride at DailyMed |
Recent Clinical Trials for dyclonine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Changhai Hospital | Phase 4 |
| Aaron Cumpston, PharmD | Phase 2 |
| Aaron Cumpston, PharmD, BCOP | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for dyclonine hydrochloride
US Patents and Regulatory Information for dyclonine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | DYCLONE | dyclonine hydrochloride | SOLUTION;TOPICAL | 009925-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Septodont | DYCLOPRO | dyclonine hydrochloride | SOLUTION;TOPICAL | 200480-001 | Nov 20, 2018 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | DYCLONE | dyclonine hydrochloride | SOLUTION;TOPICAL | 009925-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Septodont | DYCLOPRO | dyclonine hydrochloride | SOLUTION;TOPICAL | 200480-002 | Nov 20, 2018 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
